Home / 510(k) Clearances / K213315

510(k) K213315

CROSSLEAD Peripheral Guide Wire by Asahi Intecc Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2022
Date Received
October 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Asahi Intecc Co., Ltd.

  • K252011 — CHIKAI Nexus petit (February 2, 2026)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)
  • K243383 — CHIKAI Nexus 014 (April 21, 2025)
  • K243733 — SION blue PLUS (April 2, 2025)
  • K241962 — Crossloop (March 27, 2025)
  • K242597 — CROSSLEAD 0.018inch (March 5, 2025)
  • K241702 — CROSSLEAD 0.014inch (February 6, 2025)
  • K241801 — Tornus ES (December 17, 2024)
  • K241510 — CROSSLEAD Tracker (August 14, 2024)

Other clearances for product code DQX

  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)